NEW YORK (Reuters Health) - A cosmetic facial filler called polyalkylimide may cause moderate to severe side effects months after injection, doctors warn in a report published today.
Cosmetic polyalkylimide injections have increasingly been used in European countries and in the United States to improve the appearance of the lips, cheeks, forehead and around the nose.
"In the early reports on polyalkylimide implant injections for cosmetic purposes, there were no significant signs of bioincompatibility" -- rejection of or reaction to the foreign material -- the researchers note in the Archives of Dermatology.
"However, more recent evidence refutes these statements, and so the complete safety of polyalkylimide implant gels can no longer be assured," Dr. Jaume Alijotas-Reig of Vall d'Hebron University Hospital, Barcelona, Spain, and colleagues warn.
In their report, they describe 25 people who developed side effects one year or longer after polyalkylimide implant injection. These side effects included swelling, hardening and swollen or tender skin lesions near the injection site, as well as more "system-wide" effects such as fever, arthritis and dry eyes or mouth.
About one third of the people had previously been injected with another implant material, the researchers note. "Perhaps in predisposed hosts, the use of more than one source of dermal filler may increase the risk of the onset of delayed immune-mediated reactions related to bioimplants," Alijotas-Reig and colleagues suggest.
After an average of about 21 months of follow-up, 11 of the 25 appeared to be free of adverse effects, whereas 10 still had recurrent bouts.
It's unclear exactly how often these types of delayed side effects occur, Alijotas-Reig and colleagues note. However, they say doctors should be aware that intermediate or delayed adverse effects can occur with polyalkylimide implants just as they can with other compounds that are used as cosmetic fillers.
SOURCE: Archives of Dermatology, May 2008.
